• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64 and Ingenuity Computed Tomography XRay Systems

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Brilliance 64 and Ingenuity Computed Tomography XRay Systems see related information
Date Initiated by Firm February 15, 2013
Date Posted March 14, 2013
Recall Status1 Terminated 3 on April 11, 2014
Recall Number Z-0950-2013
Recall Event ID 64436
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems

The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code Information Brilliance 64: 728231 & Ingenuity CT: 728326, 728323.  System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 95504  System Code # 728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300014,300015,300018,300027,300041,300053,300059,300066,300070,300071,300073,300074,300078,300079,300080,300082,300084,300086,300091,300095,300101,300102,300112,300127,300128,300129,300131,300132,310064  System Code # 728323, Serial #: 320033
Recalling Firm/
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Michael McAndrew
Manufacturer Reason
for Recall
This field change order is being released to update software and customer release notes to the affected installed base.
FDA Determined
Cause 2
Software design
Action Philips Healthcare sent an Urgent Medical Device Correction letter dated February 13, 2013, via certified mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter. Customers were instructed to retain a copy with the equipment Instruction for Use. For questions customers were instructed to contact their local Phillips representative or local Philips Healthcare office. For North Americal and Canada contact Customer Care Solutions Center at 1-800-722-9377, option 5: Enter Site ID or follow the prompts For questions regarding this recall call 1-800-722-9377.
Quantity in Commerce 42 Units
Distribution Worldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, Germany, Israel, Japan, Norway, Sweeden, and Switzerland.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.